ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

Description of Event or Problem

IT WAS REPORTED THAT A PT UNDERWENT AN ORTHOPEDIC SURGICAL PROCEDURE ON THE SPINO-CERVICAL MUSCLE ON (B)(6) 2010. DURING THE PROCEDURE, THE NEEDLE BROKE WHEN PASSING THROUGH THE MUSCLES. THE TIP END OF THE NEEDLE WAS LOST IN-SITU. THE SEARCH FOR THE NEEDLE FRAGMENT EXTENDED THE OPERATION TIME. A NEW OPERATION UNDER SCANNER IS FORESEEN IN THE FUTURE TO RETRIEVE THE PIECE OF NEEDLE.

Additional Manufacturer Narrative

(B)(4): RESULTS: THE ACTUAL RETURNED DEVICE WAS EVALUATED. THE VISUAL INSPECTION OF THE INCRIMINATED PIECE OF NEEDLE SHOWS NEEDLE HOLDER MARKS AROUND THE BREAKAGE AREA (SWAGING AREA). THE DEVICE INFO FOR USE CAUTIONS THE USER THAT "TO AVOID DAMAGING NEEDLE POINTS AND SWAGE AREAS, GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE SWAGED END TO THE POINT." REPRESENTATIVE SAMPLES OF THE PRODUCT WAS TESTED FOR NEEDLE STRENGTH AND DUCTILITY AND THE RESULTS OBTAINED WERE IN CONFORMANCE WITH THE REQUIREMENTS. NO DEVICE FAILURE DETECTED AND THE PRODUCT IS WITHIN SPECIFICATION. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.